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Phase III study shows everolimus delays tumor progression in hard-to-treat neuroendocrine tumors
Date:10/12/2010

The results of a large Phase-III clinical trial have shown that the drug everolimus delays tumor progression in patients with a hard-to-treat group of rare cancers that affect particular hormone-producing cells.

At the 35th Congress of the European Society for Medical Oncology (ESMO), Dr Marianne Pavel from Charit University in Berlin, Germany reported that everolimus improved progression-free survival by 5.1 months in patients with advanced neuroendocrine tumors.

Neuroendocrine tumors are slow-growing malignancies that originate from cells of the body's neuroendocrine system. These cells are found throughout the body in organs such as the gastrointestinal tract and the lungs. The tumors are mostly non-responsive to chemotherapy drugs. They affect less than five people in 100,000, and until now there have been few treatment options for inhibition of tumor growth.

In the new RADIANT-2 trial, researchers in several European countries and the USA treated 429 patients with progressing, well- or moderately-differentiated advanced neuroendocrine tumors with either everolimus plus a somatostatin analog called octreotide LAR, or placebo plus octreotide LAR.

All patients had a history of 'carcinoid' symptoms, meaning the tumors have been secreting excessive levels of amines, especially serotonin, leading to symptoms such as flushing and diarrhea. The tumor originated in the small intestine in about 50% of patients.

Overall, the median progression-free survival for patients given everolimus plus octreotide LAR was 16.4 months, significantly longer than the median 11.3 months for placebo plus octreotide LAR, Dr Pavel reported.

"This is the first Phase-III trial of the combination therapy with octreotide LAR and everolimus and it is the largest trial that has ever been done in this type of neuroendocrine tumors," Dr Pavel said. "When we designed the study, we tested for an improvement of at least 4.5 months compared t
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Contact: Vanessa Pavinato
media@esmo.org
European Society for Medical Oncology
Source:Eurekalert

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